Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA)

Urethral Stricture Disease Clinical Trial

— SONO-URETHRA  

Official title:

Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography: Evaluation of the Diagnostic Value and Evaluation of the Reduction of the Radiation Dose With Sono-urethrography (SONO-URETHRA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01790776
• Other study ID #: 2012/902
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Conventional urethrography is the standard diagnostic evaluation for patients with a suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV. Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic accuracy of sono-urethrography is equal compared to conventional urethrography, with even a better measurement of stricture length and degree of spongiofibrosis with sono-urethrography. However, sono-urethrography remained underused among urologists and radiologists.

Patients will be randomly assigned into two groups:

Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is inconclusive or of poor quality, a conventional urethrography will be performed.

The radiation dose in the two groups will be measured. The stricture length and location will be recorded and compared with the perioperative findings in order to evaluate the diagnostic accuracy. The complications of the procedure(s) will be recorded with a questionnaire directly after and two weeks after the conventional or sono-urethrography.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists.

Exclusion Criteria:

• Transsexual patients.

• Patients with perineostomy.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture
• Urethral Stricture Disease

Intervention

Radiation:
• Urografin 30%
Urografin 30% (Natrium amidotrizoas 10G, Megalumin, Amidotrizoas 65G, Natrii calcii edetas, water for injection 250 ml, with 146 mg iodium/ml). The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (urografin 30 %) is instilled.
• NaCl 0,9 % in aqua
The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (NaCl 0,9 % in aqua) is instilled. If the result is inconclusive, urografin 30 % will be instilled.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose during diagnostic intervention.	The radiation dose will be measured with a dosimeter.	During urethrography.
Secondary	Diagnostic accuracy of sono-urethrography vs conventional urethrography.	The results of sono-urethrography and conventional urethrography will be compared with the intraoperative situation (place stricture, length stricture); contrast allergy and complications are scored with a questionnaire.	Immediately and 2 weeks after urethrography

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